FDA Clears First COVID-19 Test That Does Not Require Prescription or Lab Visit

New Test Available for Home Use

Rapid Test Detects SARS-CoV-2 Antigen From Nasal Swab

The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the first COVID-19 test that does not require a prescription or a visit to a healthcare provider or lab.

The test, called the Ellume COVID-19 Home Test, is a rapid antigen test that can be used by individuals to detect SARS-CoV-2 antigen from nasal swab of probable COVID-19 patients.

The test is available for sale over-the-counter at pharmacies and other retail outlets and can be used by individuals at home.